Adult patients with hematological malignancies
Conditions
Interventions
Product Name: mesenchymal stem cells
Product Code: MSC
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: MSC
Concentration type: equal
Concentration number: 1 x 10E6 MSC/kg-2 x 10E6 MSC/
Sponsors
UZ Brussel VUB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria: Age 15-60 yrs with following diseases Allogeneic stem cell transplantation is the preferred treatment option: High risk acute myeloid leukemia (AML) in first complete remission (CR) High risk acute lymphoblastic leukemia (ALL) in first CR Acute leukemia in second or third remission High risk myelodysplastic syndrome: IPSS Intermediate-2 or high risk Advanced lymphoproliferative disorders Chronic myeloid leukemia Multiple myeloma Informed consent given Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient exclusion criteria Previous allogeneic transplant Progressive malignant disease Significant organ damage as a contraindication to allotransplantation Creatinine clearance 3x normal value and/or serum bilirubin > 3 mg/dL Cardiac failure (LVEF < 50%) Clinical relevant pulmonary disease: DLCO < 50% normal Significant psychiatric or neurological disorder Uncontrolled viral, fungal or bacterial infection Pregnancy HIV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the feasibility of umbilical cord blood-derived hematopoietic stem cell transplantation with co-infusion of third party mesenchymal stem cells as assessed by the treatment-related mortality at d100 after transplant. ;Secondary Objective: ? Chimerism at multiple time points ? Hematopoietic recovery (neutrophil and platelet engraftment) ? Immune recovery ? Incidence of acute and chronic graft-versus-host disease (GVHD) ? Infectious complications ? Disease free survival ? Relapse incidence ? Overall survival ;Primary end point(s): The primary objective of this study is to determine the feasibility of umbival cord blood-derived hematopoietic stem cell transplantation with co-infusion of third party mesenchymal stem cells as assessed by the treatment-related mortality at d100 after transplant. | — |
Countries
Belgium
Outcome results
None listed